Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-02 @ 7:58 AM
Study NCT ID:
NCT04600557
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2020-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Compassion-based Intervention for Internal and External Shame
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are not told which arm they are assigned to'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to one of four conditions throughout the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2020-10-10', 'studyFirstSubmitQcDate': '2020-10-18', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Internal shame', 'timeFrame': 'One-week post-intervention', 'description': 'Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)'}, {'measure': 'Internal shame', 'timeFrame': '5 minutes post-intervention', 'description': 'Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)'}, {'measure': 'External shame', 'timeFrame': 'One-week post-intervention', 'description': 'Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)'}, {'measure': 'External shame', 'timeFrame': '5 minutes post-intervention', 'description': 'Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)'}], 'secondaryOutcomes': [{'measure': 'Shame activation', 'timeFrame': '5 minutes post-intervention', 'description': 'Real-time assessment of shame activation during shame memory recall tasks (range: 0-100)'}, {'measure': 'Shame activation', 'timeFrame': 'one-week follow-up', 'description': 'Real-time assessment of shame activation during shame memory recall tasks (range: 0-100)'}, {'measure': 'State shame', 'timeFrame': '5 minutes post-intervention', 'description': 'Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame)'}, {'measure': 'State shame', 'timeFrame': 'one-week follow-up', 'description': 'Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame)'}, {'measure': 'Electrodermal response to shame', 'timeFrame': '5 minutes post-intervention', 'description': 'Measured in microsiemens (μS) by Empatica E4 during shame memory recall tasks'}, {'measure': 'Electrodermal response to shame', 'timeFrame': 'one-week follow-up', 'description': 'Measured in microsiemens (μS) by Empatica E4 during shame memory recall tasks'}, {'measure': 'Blood volume pulse in reaction to shame', 'timeFrame': '5 minutes post-intervention', 'description': 'Changes in blood volume measured by Empatica E4 during shame memory recall tasks'}, {'measure': 'Blood volume pulse in reaction to shame', 'timeFrame': 'one-week follow-up', 'description': 'Changes in blood volume measured by Empatica E4 during shame memory recall tasks'}, {'measure': 'Motion in reaction to shame', 'timeFrame': '5 minutes post-intervention', 'description': 'Measured by 3-axis accelerometer sensor in the range \\[-2g, 2g\\] using Empatica E4 during shame memory recall tasks'}, {'measure': 'Motion in reaction to shame', 'timeFrame': 'one-week follow-up', 'description': 'Measured by 3-axis accelerometer sensor in the range \\[-2g, 2g\\] using Empatica E4 during shame memory recall tasks'}, {'measure': 'Skin temperature reaction to shame', 'timeFrame': '5 minutes post-intervention', 'description': 'Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks'}, {'measure': 'Skin temperature reaction to shame', 'timeFrame': 'one-week follow-up', 'description': 'Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['compassion', 'self-compassion', 'shame'], 'conditions': ['Shame', 'Compassion']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Cook, D. R. Measuring shame: the internalized shame scale. Alcoholism Treatment Quarterly, 1987; 4, 197- 215.'}, {'type': 'BACKGROUND', 'citation': 'del Rosario, P.M., & White, R.M. The Internalized Shame Scale: Temporal stability, internal consistency, and principal components analysis. Personality and Individual Differences. 2006; 41, 95-103.'}, {'type': 'BACKGROUND', 'citation': 'Goss, K., Gilbert, P., & Allen, S. An exploration of shame measures-I: The Other As Shamer scale. Person. Individ. Diff.,1994; 17(5), 713-717.'}, {'pmid': '11931676', 'type': 'BACKGROUND', 'citation': 'Andrews B, Qian M, Valentine JD. Predicting depressive symptoms with a new measure of shame: The Experience of Shame Scale. Br J Clin Psychol. 2002 Mar;41(Pt 1):29-42. doi: 10.1348/014466502163778.'}, {'type': 'BACKGROUND', 'citation': 'Neff, K.D. The development and validation of a scale to measure self-compassion. Self and Identity. 2003; 2, 223-250.'}, {'type': 'BACKGROUND', 'citation': 'Rybak, C.J. & Brown, B. Assessment of internalized shame: Validity and reliability of the Internalized Shame Scale. Alcoholism Treatment Quarterly. 1996; 14:1.'}, {'type': 'BACKGROUND', 'citation': 'American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing. 2013.'}, {'pmid': '28270331', 'type': 'BACKGROUND', 'citation': 'Au TM, Sauer-Zavala S, King MW, Petrocchi N, Barlow DH, Litz BT. Compassion-Based Therapy for Trauma-Related Shame and Posttraumatic Stress: Initial Evaluation Using a Multiple Baseline Design. Behav Ther. 2017 Mar;48(2):207-221. doi: 10.1016/j.beth.2016.11.012. Epub 2016 Nov 29.'}, {'pmid': '9210990', 'type': 'BACKGROUND', 'citation': 'Gilbert P. The evolution of social attractiveness and its role in shame, humiliation, guilt and therapy. Br J Med Psychol. 1997 Jun;70(2):113-47. doi: 10.1111/j.2044-8341.1997.tb01893.x.'}, {'type': 'BACKGROUND', 'citation': 'Gilbert, P. What Is shame? Some core issues and controversies. In Shame: Interpersonal behavior, psychopathology, and culture. 1998.'}, {'type': 'BACKGROUND', 'citation': 'Gilbert, P., & Procter, S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. In Clinical Psychology and Psychotherapy. 2006; 13(6): 353-379. https://doi.org/10.1002/cpp.507'}, {'type': 'BACKGROUND', 'citation': "Johnson, E. A., & O'Brien, K. A. Self-Compassion Soothes the Savage EGO-Threat System: Effects on Negative Affect, Shame, Rumination, and Depressive Symptoms. Journal of Social and Clinical Psychology. 2013; 32(9), 939-963. https://doi.org/10.1521/jscp.2013.32.9.939"}, {'type': 'BACKGROUND', 'citation': 'Judge, L., Cleghorn, A., McEwan, K., & Gilbert, P. An exploration of group-based compassion focused therapy for a heterogeneous range of clients presenting to a community mental health team. International Journal of Cognitive Therapy. 2012. https://doi.org/10.1521/ijct.2012.5.4.420'}, {'pmid': '21219057', 'type': 'BACKGROUND', 'citation': 'Kim S, Thibodeau R, Jorgensen RS. Shame, guilt, and depressive symptoms: a meta-analytic review. Psychol Bull. 2011 Jan;137(1):68-96. doi: 10.1037/a0021466.'}, {'type': 'BACKGROUND', 'citation': 'Lewis, M. Shame: The exposed self. New York: Free Press. 1992.'}, {'type': 'BACKGROUND', 'citation': 'Lewis, M. The role of the self in shame. Social Research, 70, 1181-1204. 2003.'}, {'pmid': '22040285', 'type': 'BACKGROUND', 'citation': 'Luoma JB, Kohlenberg BS, Hayes SC, Fletcher L. Slow and steady wins the race: a randomized clinical trial of acceptance and commitment therapy targeting shame in substance use disorders. J Consult Clin Psychol. 2012 Feb;80(1):43-53. doi: 10.1037/a0026070. Epub 2011 Oct 31.'}, {'type': 'BACKGROUND', 'citation': 'Skinta, M. D., Lezama, M., Wells, G., & Dilley, J. W. Acceptance and Compassion-Based Group Therapy to Reduce HIV Stigma. Cognitive and Behavioral Practice. 2015. https://doi.org/10.1016/j.cbpra.2014.05.006'}]}, 'descriptionModule': {'briefSummary': 'This is a four-arm randomized pilot study aimed at reducing internal and/or external shame using self-compassion and/or compassion from others. The study is designed to test the theory that trait shame is comprised of both internal and external shame and to test compassion for others as an intervention for external shame.', 'detailedDescription': 'Shame is a common, painful emotion involving negative evaluations of the self. It has been theorized that trait shame involves both internal shame (i.e., evaluating oneself negatively) and external shame (i.e., perceiving that others evaluate the self negatively). Shame is experienced across a variety of psychiatric illnesses, yet it has been highly understudied.\n\nSelf-compassion has been used as an intervention for reducing shame in a variety of research studies, often in the context of a specific psychiatric disorder. However, self-compassion interventions, which aim to change the way one thinks and feels about oneself, may specifically target internal shame but not external shame. It is proposed that receiving compassion from others is an analogous and plausible intervention for external shame. In order to test the theory that trait shame is comprised of both internal and external shame and to test compassion for others as an intervention for external shame, a four-arm randomized pilot study aimed at reducing internal and/or external shame using self-compassion and/or compassion from others is proposed here.\n\nParticipants (N=180) scoring high on both internal and external shame on self-report measures will be assessed at baseline using both questionnaires and a shame-memory recall. Participants will be randomized to one of four conditions: a) describing a shameful experience using a self-compassionate prompt and receiving no verbal responses from confederates (self-compassion only), b) describing a shameful experience using a neutral prompt and receiving compassionate responses from confederates (compassion from others only), c) both describing a shameful experience using a self-compassionate prompt and receiving compassionate responses from confederates (self-compassion plus compassion from others), or d) describing a shameful experience using a neutral prompt and receiving no verbal responses from confederates (sharing-only control). Participants will complete questionnaires and shame-memory recalls again immediately following the sharing intervention and at a one-week post-intervention follow-up.\n\nThe two primary outcome measures will be state internal shame, as measured by the Internalized Shame Sclae, and state external shame, as measured by the Other As a Shamer scale. Both the Internalized Shame Scale and Other As a Shamer scale will be administered at baseline (immediately pre-treatment), immediately post-treatment, and a one-week post-intervention follow-up. Secondary outcome measures will include the Positive and Negative Affect Scale, and a real-time assessment of state shame.\n\nIt is expected that (a) participants assigned to describe a shameful experience using self-compassionate instructions will display larger reductions in internal shame relative to those assigned to describe a shameful experience using neutral instructions; (b) participants who receive compassionate responses from others after sharing a shameful experience will display larger reductions in external shame relative to those assigned to a listening-only control; and (c) participants assigned to describe a shameful experience using self-compassionate instructions combined with receiving compassionate responses from others will display larger reductions in both internal and external shame relative to participants who receive either component alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elevated levels of internal and external shame\n* Can recall two shameful experiences\n\nExclusion Criteria:\n\n* Active suicidal ideation as measured by endorsement of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance) on BDI-II item 9\n* Endorses intent to harm or kill others'}, 'identificationModule': {'nctId': 'NCT04600557', 'briefTitle': 'A Compassion-based Intervention for Internal and External Shame', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'A Compassion-based Intervention for Internal and External Shame', 'orgStudyIdInfo': {'id': '2018-07-0058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-compassion only', 'description': 'Describing a shameful experience using a self-compassionate prompt and receiving no verbal responses from confederates', 'interventionNames': ['Behavioral: Describing a shameful experience using a self-compassionate prompt', 'Behavioral: Receiving no response from confederates']}, {'type': 'EXPERIMENTAL', 'label': 'Compassion from others only', 'description': 'Describing a shameful experience using a neutral prompt and receiving compassionate responses from confederates', 'interventionNames': ['Behavioral: Receiving compassionate responses from confederates', 'Behavioral: Describing a shameful experience using a neutral prompt']}, {'type': 'EXPERIMENTAL', 'label': 'Self-compassion plus compassion from others', 'description': 'Both describing a shameful experience using a self-compassionate prompt and receiving compassionate responses from confederates', 'interventionNames': ['Behavioral: Describing a shameful experience using a self-compassionate prompt', 'Behavioral: Receiving compassionate responses from confederates']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sharing-only control', 'description': 'Describing a shameful experience using a neutral prompt and receiving no verbal responses from confederates', 'interventionNames': ['Behavioral: Describing a shameful experience using a neutral prompt', 'Behavioral: Receiving no response from confederates']}], 'interventions': [{'name': 'Describing a shameful experience using a self-compassionate prompt', 'type': 'BEHAVIORAL', 'otherNames': ['Self-compassionate prompt'], 'description': 'Participants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt', 'armGroupLabels': ['Self-compassion only', 'Self-compassion plus compassion from others']}, {'name': 'Receiving compassionate responses from confederates', 'type': 'BEHAVIORAL', 'otherNames': ['Compassionate confederates'], 'description': "Following the participant's description of a shameful experience, two confederates will respond with compassionate responses", 'armGroupLabels': ['Compassion from others only', 'Self-compassion plus compassion from others']}, {'name': 'Describing a shameful experience using a neutral prompt', 'type': 'BEHAVIORAL', 'otherNames': ['Neutral prompt'], 'description': 'Participants will be instructed to describe a shameful experience to two confederates using a neutral (i.e., not self-compassionate) prompt', 'armGroupLabels': ['Compassion from others only', 'Sharing-only control']}, {'name': 'Receiving no response from confederates', 'type': 'BEHAVIORAL', 'otherNames': ['Neutral confederates'], 'description': "Following the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response", 'armGroupLabels': ['Self-compassion only', 'Sharing-only control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Michael J Telch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Psychology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology', 'investigatorFullName': 'Michael J. Telch', 'investigatorAffiliation': 'University of Texas at Austin'}}}}